Sartell Pediatrics

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of three 2019 proficiency testing (PT) scores when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Hematology and Urinalysis testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory on 12/29/20, at 10:05 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) as PT provider. 3. The following PT events / samples / test results were not graded by API due to lack of consensus. See below. Event Sample ID Analyte Heme / Coag US-02 Urine Sediment 2019 / 1st Heme / Coag QBC-06 WBC Count 2019 / 2nd Heme / Coag QBC-15 WBC Count 2019 / 3rd 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test results. The data summary for the above analytes were not present in laboratory records. Evaluation of the non-graded results were not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded results upon request. 5. In an interview on 12/29/20, at 10:45 p.m., TP1 confirmed the above finding . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to evaluate an unacceptable proficiency testing (PT) result. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 09/11/18 at 10:05 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. The laboratory received an unacceptable PT result from API in the third Hematology event of 2018 for White Blood Cell count. See below Event Sample ID Lab result API range 2017-3 QBC-12 25.8 27.2-37.0 4. An evaluation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide an evaluation upon request. 5. In an interview on 09 /11/18 at 11:25 a.m., TP1 confirmed an evaluation of the unacceptable result was not performed. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- failed to verify the accuracy of a non-graded proficiency testing (PT) result. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory on 09/11/18 at 10:05 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. The laboratory received non-graded results from API due to no consensus in the first Hematology event of 2018 for White Blood Cell count. The laboratory's result was not within the API expected range. See below Event Sample ID Lab result API range 2018-1 QBC-04 19.3 20.5-27.9 4. An evaluation of the non-graded PT result was not found during review of laboratory records. The laboratory was unable to provide an evaluation upon request. 5. In an interview on 09/11/18 at 11:25 a.m., TP1 confirmed an evaluation of the non-graded PT result was not performed. -- 2 of 2 --